Director Analytical Development

Director Analytical Development

AbbVie

Ludwigshafen, Germany

Abbvie Product Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy Group is responsible for driving the analytical CMC control strategy for late-stage development of biologics. The Analytical CMC Strategy team is responsible for ensuring late phase to commercial method development, optimization, validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works cross-functionally with process development, regulatory, and quality within the Abbvie network. We're looking for a Director Analytical Development to join the team. This role requires a strategic thinker with a strong technical analytical background and the ability to lead an analytical team, manage complex projects, and effectively communicate cross-functionally.

Job Description

Make an impact:

• Lead a team of senior analytical strategy leads for the development and commercialization of Abbvie’s late-stage biologics pipeline;
• Driving overall control strategy, including justifying appropriate specifications, determining critical quality attributes, and risk-based comparability strategies for the biologics pipeline;
• Establish collaborations across the organization to ensure delivery of critical analytical BLA enabling activities;
• Setting team strategies, managing resources and defining risk mitigation strategies;
• Act as the principal contact for all stakeholders and balance conflicting expectations between cross-functional areas;
• Communicate project strategy, key issues, and risks to relevant teams and escalate risks and facilitate resolution within/across functional areas.

Qualifications

Your profile:

• PhD in analytical chemistry or related field with 8 years of related experience or Master’s Degree with 14 years of related experience;
• Technical expertise in CMC analytical chemistry;
• Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies;
• Ability to interact well with diverse groups within function and maintains strong working relationships with internal and external collaborators.